BEUDAMED
    FDA Enforcement Class II Terminated

    Proton therapy system -Proteus 235 aka Proteus Plus. A medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.

    Recall: Z-2097-2017 · Reported May 24, 2017

    Enforcement

    Recall Number
    Z-2097-2017
    Event ID
    76977
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ion Beam Applications S.A.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 24, 2017
    Initiation Date
    April 10, 2017
    Classification Date
    May 16, 2017
    Termination Date
    February 16, 2018
    Address
    Chemin du Cyclotron, 3, Louvain La Neuve, N/A, Belgium

    Description

    Proton therapy system -Proteus 235 aka Proteus Plus. A medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.

    Reason

    A PBS (Pencil Beam Scanning) irradiation may pause for different reasons. After a pause, irradiation may restart from the beginning instead of recalculating the field based on the already delivered dose.

    Code Info

    Serial numbers: PAT.003, PAT.006

    Distribution

    FL

    Quantity

    2